Nerve cuff, method and apparatus for manufacturing same

ABSTRACT

A nerve cuff comprising a wall band member having an inner surface defining a lumen when the wall band member is in a closed configuration for receiving a nerve therethrough. At least one longitudinal and contiguous conductor extends within the lumen. The conductor is insulated and has at least one exposed portion thereby providing an electrode. When mounting the nerve cuff to a nerve, each electrode is in electrical communication with the nerve. A multi-channel nerve cuff further comprises a plurality of longitudinal ridges formed on the inner surface with each adjacent pair of ridges defining a longitudinal chamber. Each chamber comprises a respective conductor extending therein. When mounting the multi-channel nerve cuff to the nerve, the ridges abut the nerve providing for each chamber to isolate respective longitudinal portions of the nerve. A method and an apparatus for manufacturing such nerve cuffs are also disclosed.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present applications requests priority on U.S. ProvisionalApplication Ser. No. 60/810,130 which was filed on Jun. 2, 2006 andwhich is incorporated herein by reference in its entirety.

FIELD OF THE INVENTION

The present invention relates to a nerve cuff for stimulating andmonitoring electrical activity in nerve tissues in human beings andother creatures possessing a nervous system. The present invention alsorelates to method and apparatus for manufacturing a nerve cuff.

BACKGROUND OF THE INVENTION

Various types of cuff transducers intended for use as electrical orchemical interfaces with neural tissue have been described in theliterature. These nerve cuffs typically have a tubular biocompatibledielectric material wall. In nerve cuffs designed to provide anelectrical interface to tissues inside the nerve cuff, the inside of thenerve cuff wall supports one or more metal electrodes. Leads from theelectrodes extend through and are supported by the nerve cuff wall. Thenerve cuff walls must be sufficiently rigid to support the leads andelectrodes. The leads may be connected to suitable signal-conditioningdevices or electrical stimulation devices.

Nerve cuff electrodes have been used in stimulation systems with thegoal of providing partial voluntary control of muscles that have beenparalyzed as a result of lesions caused by spinal cord injury, stroke,or other central neurological system disorders. In some cases, partialmotor function may be restored by stimulating motor neurons or musclesbelow the level of the lesion. Nerve cuffs may also be used as sourcesfor the measurement of the neurological signal of the peripheral nervoussystem and for feedback of closed-loop functional electrical stimulation(FES) systems.

As such, there is increasing interest in the use of nerve cuffs topreferentially monitor and/or stimulate activity in selected axonswithin a nerve bundle. Hoffer et al., U.S. Pat. No. 5,824,027, which isincorporated herein by reference in its entirety, describes amulti-channel nerve cuff having longitudinal ridges extending along theinterior walls of the nerve cuff.

The ridges divide the volume between the nerve cuff wall and the tissueswithin the nerve cuff into separate chambers. Electrodes are located inthe chambers. This cuff structure can provide improved nerve signalrecording selectivity and enhanced stimulation selectivity as comparedto conventional nerve cuffs which lack separate chambers.

Fabricating a multi-chamber, multi-channel nerve cuff having one or moreindependent electrodes in each of several chambers is challenging,especially where the cuff is small in size. It is frequently desirableto provide nerve cuffs having internal diameters of only 2-3 mm. Thechallenge is compounded by the fact that such cuffs should be fabricatedfrom material which is sufficiently flexible to minimize damage todelicate neural tissue, such as may occur with compression, sharpbending and/or stretching of the tissue. Suitable materials, such asbiocompatible silicone compositions may stretch when they aremanipulated. This flexibility in the nerve cuff wall may make itdifficult to place electrodes in precisely determined locations and tokeep the electrodes in position.

Tyler, et al. U.S. Pat. No. 5,634,462, which is incorporated herein byreference in its entirety, describes multi-channel nerve cuffsconstructed of stiff material. The Tyler et al. nerve cuffs are designedto deform and even penetrate a nerve, with the objective offapproximating electrodes to more centrally located axons in nerves. Aproblem with this type of device is the possibility that the nerve couldbe damaged by the nerve cuff.

There is a need for methods to more readily accurately fabricatemulti-channel nerve cuffs. Nerve cuffs used for making recordings ofelectrical activity within nerve tissues should provide good electricalisolation of the tissues within the nerve cuffs. There is also a needfor nerve cuffs which may provide better isolation from externallygenerated electrical noise than is provided by current cuff designs.There is further needed a nerve cuff that may be used effectively toselectively stimulate or record from targeted subpopulations of nervefibers in a nerve and may be used on nerves which could be damaged bypenetration.

OBJECTS OF THE INVENTION

An object of the present invention to provide a nerve cuff.

Another object of the present invention is to provide a multi-channelnerve cuff.

A further object of the present invention is to provide a method ofmanufacturing a nerve cuff.

Another object of the present invention is to provide an apparatus formanufacturing a nerve cuff.

SUMMARY OF THE INVENTION

in accordance with an aspect of the present invention there is provideda nerve cuff comprising: a wall band member having an inner surfacedefining a lumen when the wall band member is in a closed configurationfor receiving a nerve therethrough; and at least one longitudinal andcontiguous conductor extending within the lumen, the conductor beinginsulated and having at least one exposed portion thereof, therebyproviding an electrode, wherein, when mounting the nerve cuff to anerve, each electrode is in electrical communication with the nerve.

In an embodiment, this nerve cuff further comprises a plurality oflongitudinal ridges formed on the inner surface, each adjacent pair ofridges defining a longitudinal chamber, each chamber comprising arespective conductor extending therein, wherein, when mounting the nervecuff to the nerve, the ridges abut the nerve providing for each chamberto isolate respective longitudinal portions of the nerve.

In accordance with another aspect of the present invention, there isprovided a nerve cuff comprising: a wall band member having an innersurface defining a lumen when the wall band member is in a closedconfiguration for receiving a nerve therethrough; at least onelongitudinal protuberance on the inner surface extending within saidlumen; and at least one electrode mounted to the longitudinalprotuberance, wherein, when mounting the nerve cuff to a nerve, the atleast one longitudinal protuberance provides for the electrode to be incontact with or at least near the surface of the nerve.

In an embodiment, this nerve cuff further comprises a plurality oflongitudinal ridges formed on the inner surface, each adjacent pair ofsaid ridges defining a longitudinal chamber, each chamber comprising alongitudinal protuberance extending therein, wherein, when mounting thenerve cuff to a nerve, the ridges abut the nerve providing for eachchamber to isolate respective longitudinal portions of the nerve.

In accordance with a further aspect of the present invention, there isprovided a nerve cuff comprising: a wall band member having an innersurface defining a lumen when the wall band member is in a closedconfiguration for receiving a nerve therethrough; a plurality oflongitudinal ridges formed on the inner surface, each adjacent pair ofridges defining a longitudinal chamber; a longitudinal protuberanceextending within each chamber; and a longitudinal and contiguousconductor mounted to each longitudinal protuberance, the conductor beinginsulated and having at least one exposed portion thereof therebyproviding an electrode, wherein, when mounting the nerve cuff to anerve, the ridges abut the nerve providing for each chamber to isolaterespective longitudinal portions of the nerve, each longitudinalprotuberance providing for an electrode to be in contact with or atleast near the surface of the nerve.

In accordance with yet another aspect of the present invention there isprovided a method of manufacturing a nerve cuff, the method comprising:(a) providing a mold comprising a plurality of longitudinal grooves; (b)positioning longitudinal conductors coated with insulation withinrespective longitudinal grooves; (c) applying flexible bio-compatiblematerial on the mold with the longitudinal conductors positionedtherein; (d) curing the flexible bio-compatible material so as toprovide a wall band member with the longitudinal conductors adheredthereto; (e) ejecting the wall band member with the adhered longitudinalconductors; and (f) removing lengths of the insulation on thelongitudinal conductors thereby providing electrodes.

In an embodiment, step (b) further comprises positioning longitudinaltubes within the longitudinal grooves, step (c) comprising applyingflexible bio-compatible material on the mold with the longitudinalconductors and the longitudinal tubes positioned therein, curing in step(d) providing for the longitudinal tubes to adhere to the wall bandmember and step (e) comprising ejecting the wall band member with theadhered longitudinal conductors and longitudinal tubes.

In accordance with yet a further aspect of the invention, there isprovided an apparatus for manufacturing a nerve cuff, the apparatuscomprising: a base; at least one open mold formed within the top face ofthe base, the mold comprising longitudinal grooves for positioninglongitudinal conductors therein; end plates positioned near each end ofthe base, each end plate comprising alignment holes for aligning theconductors positioned in said grooves; and first and second conductorclamps for clamping the conductors near each longitudinal end thereofrespectively, at least one of the first and second conductor clampsbeing so moveable as to tighten the clamped conductors, wherein when theconductors are positioned in the grooves and tightened, a flexiblebio-compatible material can be applied to said mould for providing thenerve cuff.

In an embodiment, the longitudinal grooves comprise conductor groovesfor receiving conductors therein and tubing grooves for receiving tubestherein. In an embodiment, the tubing grooves comprise ridge grooves forpositioning ridge tubes therein and closure element grooves forreceiving closure element tubes therein.

In accordance with still another aspect of the present invention, thereis provided a multi-channel nerve cuff comprising a wall band memberhaving an inner surface defining a lumen when said wall band member isin a closed configuration for receiving a nerve therethrough, the innersurface defining a plurality of channels, each channel including aplurality of electrodes, each electrode of a same channel provided froma same conductor, wherein, when mounting the nerve cuff to a nerve, eachelectrode is in electrical communication with the nerve.

In an embodiment, the electrodes of the same conductor compriseindifferent electrodes and recording electrodes.

Other objects, advantages and features of the present invention willbecome more apparent upon reading of the following non restrictivedescription of illustrative embodiments thereof, given by way of exampleonly with reference to the accompanying drawings.

BRIEF DESCRIPTION OF THE FIGURES

Illustrative embodiments of the invention will be described by way ofexample only with reference to the accompanying drawings, in which:

FIG. 1 is a perspective view of a nerve cuff in a closed configurationin accordance with an illustrative embodiment of the present invention;

FIG. 2 is a perspective view of the nerve cuff of FIG. 1 in an openconfiguration;

FIG. 3 is cross sectional view of the nerve cuff taken along axisIII-III of FIG. 2;

FIG. 4A is a perspective view of a capped electrode wire;

FIG. 4B is a perspective view of an another embodiment of the cappedelectrode wire of FIG. 4A;

FIG. 5 is a perspective view of an apparatus for manufacturing a nervecuff in accordance with an illustrative embodiment of the presentinvention;

FIG. 6 is an exploded perspective view of the apparatus of FIG. 5;

FIG. 7 is cross sectional view of the apparatus taken along axis VII-VIIof FIG. 6;

FIG. 8 is a detailed view of FIG. 7;

FIG. 9 is a perspective view of an end plate of the apparatus of FIG. 5;

FIG. 10 is a perspective view of a tightness adjustment mechanism of theapparatus of FIG. 5;

FIG. 11 is an exploded perspective view of the tightness adjustmentmechanism of FIG. 10;

FIG. 12 is a flow diagram of the steps of a method of manufacturing anerve cuff in accordance with an illustrative embodiment of the presentinvention;

FIG. 13 is a perspective view of the apparatus of FIG. 5 showing thepositioning of electrode wires; and

FIG. 14 is a sectional view of the nerve cuff of FIG. 1 mounted on anerve.

DETAILED DESCRIPTION OF THE ILLUSTRATIVE EMBODIMENTS

Generally stated, an implantable interface in the form of a nerve cuff,hereinafter referred to as “nerve cuff”, according to an illustrativeembodiment of the present invention is used for stimulating and/ormonitoring electrical activity in nerve tissues in human beings or othercreatures possessing nervous systems. The interface may have particularapplication in functional electrical stimulation (“FES”) of theneuromuscular system.

Referring to FIGS. 1 and 2, there is shown a non-limitative illustrativeembodiment of a nerve cuff 10 in a closed configuration (FIG. 1) and inan open configuration (FIG. 2). The nerve cuff 10 has a wall member 20in the form of a band which has a generally tubular configuration whenin a closed configuration, as shown in FIG. 1. This wall band member orwall member 20 defines a lumen 30, when it is in the closedconfiguration, which is sized to receive a nerve or other bodily tissue.The surface of the wall band member 20 which defines the lumen 30 andwhich is interfaced to a nerve N (see FIG. 14) is the inner surface ofthe wall band member 20. A closure 22 allows the nerve cuff 10 to beopened to receive a nerve N (see FIG. 14) or other bodily tissue inlumen 30. Closure 22 may then be closed to isolate the bodily tissuewithin lumen 30. The closure 22 may be any suitable closure, however,the closure 22 advantageously comprises interdigitating closing elements24 affixed on either lateral side of the wall band member 20 combinedwith a sealing tube 25. Closure 22 may be secured in a closedconfiguration by inserting a rod-like member (not shown) throughinterdigitated closing members 24.

Five longitudinal ridges 31, 32, 33, 34 and 35 and four longitudinalconductors in the form of pairs of elevated contiguous electrode wires(41, 42), (43, 44), (45, 46) and (47, 48) extending along the innersurface within the lumen 30 delimitate, in alternating disposition,eight chambers 51, 52, 53, 54, 55, 56, 57 and 58, as best seen in FIG.2. It is to be understood that while the nerve cuff 10 of theillustrative embodiment contains eight chambers 51, 52, 53, 54, 55, 56,57 and 58, the nerve cuff 10 may have a different number of chambersand/or ridges and/or pairs of elevated electrodes, depending on theapplication.

The example shown herein is a multi-channel nerve cuff 10, yet nervecuffs with a single channel can also be provided within scope of thepresent invention. It should also be noted that the longitudinalconductors exemplified herein are not limited to pairs of wires butinclude other suitable conductors known in the art.

Other types of electrodes can also be provided within the scope of theinvention. Hence, rather than longitudinal contiguous conductors shortdiscontinuous conducting elements, whether wires or other elements canalso be contemplated.

Furthermore, in another embodiment, the wall member 20 may have a port(such as an opening) located within one or more of the chambers 51, 52,53, 54, 55, 56, 57 and 58 so as to allow connection to an agent deliverysystem for agents such as, for example, a pharmaceutical agent.

FIG. 14, illustrates the nerve cuff 10 in use mounted to a nerve N andsecured thereto via closure 22. The ridges 31, 32, 33, 34 and 35 abutthe nerve N, providing for each chamber 54, 55, 56, 57 and 58 to isolaterespective longitudinal regions of the nerve N. The electrodes(referenced herein below) are in contact or at least substantially nearthe nerve N.

In the following description, the specific components used are meant asexamples only so as to describe a functional realization of theillustrative embodiment and are not meant to limit the present inventionto these specific components.

Wall Member

The wall member 20 may be made by molding implant grade silicone, forexample room temperature vulcanizing (RTV) silicone. It is to beunderstood that other suitable implant grade may be used.

Ridges

The ridges 31, 32, 33, 34 and 35 consist of generally parallelcommercial silicone tubing such as, for example, 0.025″×0.012″ siliconetubing from Allied Biomedical (AlliedSil™). The ridges 31, 32, 33, 34and 35 enclose a ground wire 36, which may be fabricated using, forexample, a hard temper type of wire such as 316 LVM wire, 1×19×0.0012;0.006 (Fort Wayne Metals Production Number 72073; Hard temper), with a0.003″ thick ETFE insulation for a total outer diameter of 0.012″. Theground wire 36 comprises a lead 36 a and a contact section 36 b. Theground wire contact section 36 b, which is de-insulated, is sequentiallypassed through the tubing forming the ridges 31, 32, 33, 34 and 35 in asystematic pattern so that the ground wire contact portion 36 b isexposed between any two consecutive ridges 31, 32, 33, 34 and 35. As forthe ground wire lead 36 a, it remains insulated over the entire lengthfrom the edge of the nerve cuff 10 to its end for connection to somefurther interface or device (not shown).

In its suggested routing, the ground wire contact section 36 b is firstinserted through the proximal end 33 a of the middle ridge 33 to itsdistal end 33 b, then goes from the distal end 33 b of the middle ridge33 to the distal end of an adjacent ridge, for example the distal end 32b of ridge 32, to its proximal end 32 a. From the proximal end 32 a ofridge 32 the ground wire contact section 38 b goes to the proximal end31 a of outer ridge 31, to its distal end 31 b. From the distal end 31 bof ridge 31 the ground wire contact section 36 b goes to the distal end32 b of ridge 32, to its proximal end 32 a. Finally, from the proximalend 32 a of ridge 32 the ground wire contact section 36 b goes to theproximal end 33 a of middle ridge 33, to its distal end 33 b. Thiscrisscross pattern is continued through ridges 34 and 35 until it makesa final pass from the proximal end 33 a of the middle ridge 33 to itsdistal end 33 b.

The result is that the middle ridge 33 encloses three passes of theground wire contact section 36 b, the intermediate ridges 32, 34 enclosetwo passes of the ground wire contact section 36 b and the outermostground wire ridges 31, 35 enclose one pass of the ground wire contactsection 36 b.

In order to prevent the ends of the ridges 31, 32, 33, 34 and 35 tubingfrom being deformed, the radius of curvature of the ground wire contactsection 36 b as it exits the tubing may be approximately 0.8 mm and thecontact section 36 b may be generally straight between adjacent ridges.A jig can also be used in order to provide for the loops of ground wireto be consistent.

Once the ground wire 36 has been positioned within the ridges 31, 32,33, 34 and 35, the end of each ridge 31, 32, 33, 34 and 35 is sealedwith an adhesive silicone plug 37. The length of the adhesive siliconeplug 37 inside each ridge 31, 32, 33, 34 and 35 being generally fromabout 1.0 mm to 1.5 mm and protruding in a generally dome shape.

Electrodes

The wire used for the electrode wires (41, 42), (43, 44), (45, 46) and(47, 48) may be, for example, a 316 LVM wire, 1×19×0.0012; 0.006 (FortWayne Metals Production Number 72073; Hard temper), with a 0.003″ thickETFE insulation (Tempflex) for a total outer diameter of 0.012″ or PT—Ir70-30.

As best seen in FIG. 3, the pairs of electrode wires (41, 42), (43, 44),(45, 46) and (47, 48) may be positioned on top of longitudinalprotuberances 26, extending along the inner surface into the lumen 30,so as to be generally at the same level as the ridges 31, 32, 33, 34 and35 relative to the inner surface of the wall band member 20. Thiselevation with respect to the surface of the wall member 20 allows theelectrode wires (41, 42), (43, 44), (45, 46) and (47, 48) to be locatedat least near the surface the nerve or to be in contact with the nerve,this diminishes the nerve/electrode impedance and results in highersensibility to nerve activity.

In an another embodiment, the protuberances 26 may be omitted so thatthe electrode wires (41, 42), (43, 44), (45, 46) and (47, 48) or otherconducting elements lay directly upon the surface of the wall member 20.In still another embodiment, the electrode wires (41, 42), (43, 44),(45, 46) and (47, 48) or other conducting elements may be embeddedwithin the protuberances 26, the protuberances may be apertured in orderto expose the electrode wires or other conductors. In yet anotherembodiment, the electrode wires (41, 42), (43, 44), (45, 46) and (47,48) or other conducting elements are embedded within the wall member 20,with the wall member 20 being apertured in order to expose the electrodewires or other conductors.

Referring back to FIG. 2, the pairs of electrode wires (41, 42), (43,44), (45, 46) and (47, 48) are used to create electrodes (61 a, 61 b,62), (63 a, 63 b, 64), (65 a, 65 b, 66) and (67 a, 67 b, 68),respectively, in “tri-polar” or “quasi-tri-polar” configurations. Thismeans that each electrode channel 71, 72, 73 and 74 comprises twoindifferent electrodes (61 a, 61 b), (63 a, 63 b), (65 a, 65 b) and (67a, 67 b) and one recording electrode 62, 64, 66 and 68, respectively.The indifferent electrodes (61 a, 61 b), (63 a, 63 b), (65 a, 65 b) and(67 a, 67 b) may be advantageously positioned symmetrically with respectto the total length of the nerve cuff 10, a first set of indifferentelectrodes 61 a, 63 a, 65 a and 67 a being located near the proximal end10 a of the nerve cuff 10 and a second set of indifferent electrodes 61b, 63 b, 65 b and 67 b being located near the distal end 10 b of thenerve cuff 10. The recording electrodes 62, 64, 66 and 68 may beadvantageously located in the center 10 c of the nerve cuff 10.

The electrodes (61 a, 61 b, 62), (63 a, 63 b, 64), (65 a, 65 b, 66) and(67 a, 67 b, 68) may be created by removing part of the ETFE insulationof the corresponding electrode wires (41, 42), (43, 44), (45, 46) and(47, 48). By creating the indifferent electrodes (61 a, 61 b), (63 a, 63b), (65 a, 65 b) and (67 a, 67 b) from the same electrode wire 41, 43,45 and 47 for each corresponding electrode channel 71, 72, 73 and 74,this avoids welding and provides a proper impedance match. The recordingelectrodes 64, 64, 66 and 68 may be created from the remaining electrodewire 42, 44, 46 and 48 of each corresponding electrode channel 71, 72,73 and 74. The method used for the creation of the electrodes (61 a, 61b, 62), (63 a, 63 b, 64), (65 a, 65 b, 66) and (67 a, 67 b, 68) will befurther described later on.

In another alternative embodiment (not shown), the pairs of electrodewires (41, 42), (43, 44), (45, 46) and (47, 48) may be used to createelectrodes in “bi-polar” configurations. This means that each electrodechannel 71, 72, 73 and 74 comprises one indifferent electrode and onerecording electrode. The indifferent electrodes and the recordingelectrodes may be positioned at opposed ends of the nerve cuff 10. Forexample, the indifferent electrodes may be located near the proximal end10 a of the nerve cuff 10 and the recording electrodes may be locatednear the distal 10 b end of the nerve cuff 10.

Therefore, a single longitudinal and contiguous conductor such as a pairof insulated wires can be used to provide for one or more electrodeswhen removing lengths thereof, hence facilitating the manufacturing ofsuch nerve cuffs as well as their efficacy.

Electrode Capping

The electrode wires (41, 42), (43, 44), (45, 46) and (47, 48) arepositioned so as to protrude approximately 2.0 mm beyond the wall member20. The protruding ends of the electrode wires (41, 42), (43, 44), (45,46) and (47, 48) are covered by RTV silicone forming an electrode cap49, as may be seen in FIGS. 1, 2 and 4A. However, before the applicationof the RTV silicone, the outer surface 83 of the ETFE insulation on theprotruding end of the electrode wires (41, 42), (43, 44), (45, 46) and(47, 48) is etched to ensure proper bonding of the RTV silicone formingthe cap 49.

In another embodiment the electrode wires (41, 42), (43, 44), (45, 46)and (47, 48) may be cut or positioned so as not to protrude beyond thewall member 20 (not shown). In this embodiment, some RTV silicone wouldflow over the end of the electrode wires (41, 42), (43, 44), (45, 46)and (47, 48) and mainly bond to the exposed inner surface 82 of the ETFEinsulation, as shown in FIG. 4B. The issue with this embodiment is thatthe inner surface 82 of the ETFE insulation may not be etched becausethe etching solution may migrate to the core 81 of the electrode wires(41, 42), (43, 44), (45, 46) and (47, 48). Thus, the bonding of the RTVsilicone to the electrode wires (41, 42), (43, 44), (45, 46) and (47,48) is not as strong as in the illustrative embodiment. Therefore, thesilicone cap 49 could possibly separate from the end of the electrodewires (41, 42), (43, 44), (45, 46) and (47, 48) and allow for the core81 to be exposed.

Closure

The closure 22 is fabricated from a single length of implant gradecommercial silicone tubing, for example AlliedSil™ Tubing 0.012″×0.025″.In the illustrative embodiment shown in FIGS. 1 and 2, the tubing is cutinto closing elements 24 in the form of tubular links on each side ofthe nerve cuff 10 to realize a piano hinge interlocking system. Theclosing elements 24 on one side of the nerve cuff 10 are combined with asealing tube 25 extending the whole length of the nerve cuff 10. Whenthe nerve cuff 10 is in a closed configuration, as best seen in FIG. 1,the sealing tube 25 rest right under the closure 22 filling the spacebetween outer ridges 31 and 35, effectively creating a seal preventingbodily fluids from passing through the closure 22. As mentionedpreviously, the closure 22 may be secured in the closed configuration byinserting a rod-like member, for example a standard permanentpolypropylene suture wire, through the interdigitated closing members24.

It is to be understood that the sealing tube 25 may be any othersuitable sealing means bridging the gap between outer ridges 31 and 35,or may be filled instead of hollow.

Cuff Width, Nerve Circumference, Ridge and Closing Members TubingDiameter Relation

For a single nerve cuff 10, Equation 1 shows the relationship betweennerve cuff width (W), nerve circumference (NC), ridge tubing diameter(φRT) and closing members tubing diameter (CE).NC=W+4.1416·CE−6.2832·φRT−2.3939 mm.  Equation 1Manufacturing

The nerve cuff 10 may be manufactured using a cast silicone processperformed in an apparatus 100 for manufacturing a nerve cuff having openmolds 102A and 102B, as shown in FIGS. 5 and 6. Although the illustratedembodiment of the molding apparatus 100 shows two molds 102A and 102B,it is to be understood that the molding apparatus 100 may have a singlemold or more than two molds.

The molds 102A and 102B are formed within the top face of a base 104 onwhich are operatively connected electrode wire clamps 106, tubing clamps108, end plates 109 and tightness adjustment mechanisms 200. Guidingmembers 110, which are inserted into guiding slots 111, are used toproperly align the end plates 109 and tightness adjustment mechanisms200 to base 104, while securing members 112 interact with securing slots113 to secure the electrode wire clamps 106, the tubing clamps 108 andthe end plates 109 to the base 104.

A coating is applied to the molds 102A and 102B to prevent the RTVSilicone form bonding to the molds 102A and 102B. The coating may be,for example, a one time spray-on baked finish Teflon coating (ProteKote840) by Pro-Tek Coatings or Poly-Ond by Polycoatings. The coating maybe, for example a spray-on baked finish as PFA coating (420-703 Primerand 857-210 Topcoat) by Dupont or Liquid bath process deposition(Poly-Ond by Polycoatings) to give but a few examples.

Referring to FIGS. 7 and 8, the molds 102A and 102B grooves 130 may becreated in the base 104 using wire electric discharge machining (EDM) orhigh speed CNC machining. The grooves 130 serve to properly retain thesilicone tubes 24, 31, 32, 33, 34 and 35 and electrode wires 41, 42, 43,44, 45, 46, 47 and 48 during the molding process. The two grooves 130 athat retain the closing elements 24 tubing are not as deep as the ridges31, 32, 33, 34 and 35 tubing grooves 130 b and the electrode wires 41,42, 43, 44, 45, 46, 47 and 48 grooves 130 c due to the cuff geometry.

Referring now to FIG. 13, the closing elements 24 tubing and ridges 31,32, 33, 34 and 35 tubing are secured into their respective grooves 130 aand 130 b by the tubing clamps 108 and associated securing members 112.As for the electrode wires 41, 42, 43, 44, 45, 46, 47 and 48, they arealigned in their respective grooves 130 c by having each of their endspass through alignment holes 122 in the end plates 109, best seen inFIG. 9, secured at one end using wire clamps 106 and associated securingmembers 112, and their tightness adjusted using the tightness adjustmentmechanism 200.

Referring to FIGS. 10 and 11, the tightness adjustment mechanism 200includes a main body 201 and an electrode clamp 202, which may besecured to the main body 201 using associated securing members 212 andcorresponding securing slots 213. Since the electrode wires 41, 42, 43,44, 45, 46, 47 and 48 secured by the tightness adjustment mechanism 200comprise part of the final product, 2 flexible silicone rubber platesare glued on the main body 201 and the electrode clamp 202, best seen inFIG. 6, to protect the electrode wires 41, 42, 43, 44, 45, 46, 47 and 48when secured by the electrode clamp 202. The flexible silicone rubberplates made of high-consistency rubber (HCR) are cut in commercialimplantable sheet grade from Allie Biomedical. When the electrode wires41, 42, 43, 44, 45, 46, 47 and 48 are secured between the main body 201and the electrode clamp 202, the tightness of the electrode wires 41,42, 43, 44, 45, 46, 47 and 48 may be adjusted by rotating the tightnessadjustment member 214. The tightness adjustment member 212, which isinserted in a threaded hole 215 within the main body 201, may be rotateduntil it enters in contact with the end plate 109, which displaces thetightness adjustment mechanism 200 away from the base 104 of the moldingapparatus 100. The tightness adjustment member 214 may then be rotated,moving the tightness adjustment mechanism 200 farther away, until thedesired tightness of the electrode wires 41, 42, 43, 44, 45, 46, 47 and48 is achieved.

The method for manufacturing of the nerve cuff 10 is depicted by theflow diagram shown in FIG. 12. The steps of the method are indicated byblocks 302 to 334. The method begins at block 302 where the mold iscleaned, for example with a 70% 2-propanol solution.

Then, at block 304, the electrode wires 41, 42, 43, 44, 45, 46, 47 and48 are cut to appropriate lengths and etched. The etching ensures anappropriate adherence between the RTV silicone and ETFE coated electrodewires 41, 42, 43, 44, 45, 46, 47 and 48.

At block 306, the electrode wires 41, 42, 43, 44, 45, 46, 47 and 48 areinserted inside the alignment holes 122 of the end plates 109, which arethen positioned such that the electrode wires 41, 42, 43, 44, 45, 46, 47and 48 rest in their corresponding grooves 130 c and secured to the base104 of the molding apparatus 100 using the guiding members 110 andsecuring members 112. The strain of the electrode wires 41, 42, 43, 44,45, 46, 47 and 48 is then adjusted with tightness adjustment mechanism200.

At block 308, the closing elements 24 tubing and the ridges 31, 32, 33,34 and 35 tubing are placed in their respective grooves 130 a and 130 b.Advantageously, small stainless steel rods may be positioned inside theclosing elements 24 tubing and the ridges 31, 32, 33, 34 and 35 tubingin order to prevent movement during the molding process and insure theirproper alignment. The electrode wire clamps 106 and tubing clamps 108are then tightened, using their respective securing members 112, toprevent displacement of the closing elements 24 tubing, the ridges 31,32, 33, 34 and 35 tubing and the electrode wires 41, 42, 43, 44, 45, 46,47 and 48.

Then, at block 310, implant grade silicone 120, for example RTVsilicone, is poured onto the mold 102 to form the wall member 20. Thewall member 20 serves to adhere to and support the closing elements 24along both edges of the nerve cuff 10, the ridges 31, 32, 33, 34 and 35and the electrode wires 41, 42, 43, 44, 45, 46, 47 and 48. To ensurethat the thickness of the wall member 20 is generally uniform throughoutthe nerve cuff 10, excess silicone is removed with, for example, a cleanTeflon coated razor blade using flat surfaces 105, as may be seen inFIG. 13, on each side of the mold 102 as guides. Advantageously, thelength of the mold 102 may be twice the length of the nerve cuff 10.This is to help stabilize the razor blade movement over the implantgrade silicone 120 and provide a good surface finish. It isadvantageous, in order to avoid flash (spilling), the blade is passed asecond time hence, step 310 can be repeated which will result in a moreconsistent thickness.

At block 312, the wall member 20 is ejected from the mold 102. It is tobe understood that the wall member 20 is not to be ejected from the mold102 until a suitable amount of time has elapsed since the pouring of theimplant grade silicone 120 to allow the implant grade silicone 120 toproperly cure. This period of time may vary depending on the type ofimplant grade silicone 120 used, for example a period of 24 hours may beused in the case of RTV silicone.

At block 314, the electrodes (61 a, 61 b, 62), (63 a, 63 b, 64), (65 a,65 b, 66) and (67 a, 67 b, 68) are created by removing lengths of ETFEinsulation from the electrode wires 41, 42, 43, 44, 45, 46, 47 and 48.The ETFE insulation may be removed using, for example, a CO₂ TEA(transverse excited atmospheric) laser for a first rough pass followedby an Excimer laser to remove the thin layer of coating that may havebeen left by the CO₂ TEA, thus exposing the core 81 of the electrodewires 41, 42, 43, 44, 45, 46, 47 and 48. The indifferent electrodes (61a, 61 b), (63 a, 63 b), (65 a, 65 b) and (67 a, 67 b) being positionedgenerally symmetrically at the extremities of the nerve cuff 10 whilethe recording electrodes are generally positioned in the center of thenerve cuff 10 with respect to its total length.

Then, at block 316, the closing elements 24 are cut from the closingelements 24 tubing using, for example, a Nd-Yag laser (or a Co2 TEAlaser) for example, such that the closing elements 24 on each side ofthe nerve cuff 10 form an interdigitating pattern such as shown in FIG.2.

At block 318, the electrode wires 41, 42, 43, 44, 45, 46, 47 and 48 arecut using, for example, a Nd-Yag laser (or a Co2 TEA laser) or cutters,such that they protrude beyond the desired length of the wall member 20by approximately 2.0 mm.

At block 320, the unused portion of the wall member 20 is cut to thedesired length using, for example, pliers, cutters and the like.

Then, at block 322, the sealing tube 25 is bound between one set ofclosing elements 24 and one of the ridges 31 or 35 tubing at theextremities of the nerve cuff 10 using, for example, implantable gradesilicone. In the illustrative embodiment shown in FIG. 2, the sealingtube 25 is bound between one set of closing elements 24 and the tuningof ridge 35.

At block 324, the protruding ends of the electrode wires 41, 42, 43, 44,45, 46, 47 and 48 are covered by implantable grade silicone, forming anelectrode cap 49 as shown in FIG. 4A.

At block 326, the ETFE coating of the contact section 36 b of the groundwire 36 is removed using, for example, a scalpel. The length of thecontact section 36 b will vary depending on the length of the nerve cuff10. The contact section 36 b of the ground wire 36 is then insertedinside the proximal end 33 a of central ridge 33 tubing and follows thepath defined previously in the description of the illustrativeembodiment nerve cuff 10.

Then, at block 328, the proximal ends 31 a, 32 a, 33 a, 34 a and 35 aand distal ends 31 b, 32 b, 33 b, 34 b and 35 b of the ridges 31, 32,33, 34 and 35 tubing are sealed with implantable grade silicone toprevent displacement of the ground wire 36. The implantable gradesilicone introduced at each end of each ridges 31, 32, 33, 34 and 35forms sealing caps 37 as shown in FIGS. 1 and 2.

At block 330, a connector (not shown) may be connected to the contactsection 36 b of the ground wire 36 and to the electrode wires 41, 42,43, 44, 45, 46, 47 and 48 for connection of the nerve cuff 10 to somefurther interface or device (not shown).

At block 332, the nerve cuff 10 is cleaned with, for example, a 70%2-propanol solution and, at block 234, it is package sterile packagingfor storage or shipment.

Although the present invention has been described by way of particularembodiments and examples thereof, it should be noted that it will beapparent to persons skilled in the art that modifications may be appliedto the present particular embodiment without departing from the scope ofthe present invention.

1. A nerve cuff comprising: a wall band member having proximal anddistal ends thereof, an inner surface defining a lumen extending betweenthe proximal end and the distal end when said wall band member is in aclosed configuration for receiving a nerve therethrough; and at leastone pair of contiguous conductors extending along the inner surfacebetween the proximal end and the distal end, wherein each conductor ofthe at least one pair of contiguous conductors comprises at least oneexposed portion situated between the proximal end and the distal end andwherein the remaining portion of each conductor of the at least one pairof contiguous conductors is insulated, thereby providing at least twoelectrodes, wherein, when mounting said nerve cuff to a nerve, saidelectrodes are in electrical communication with the nerve.
 2. The nervecuff according to claim 1, further comprising at least two ridges formedon said inner surface and extending between the proximal end and thedistal end, wherein a pair of the at least one pair of contiguousconductors is situated between each adjacent pair of ridges, whereineach adjacent pair of ridges and each portion of the inner surfacesituated between the adjacent pair of ridges defines a chamber, wherein,when mounting said nerve cuff to the nerve, said ridges abut the nerveproviding for each said chamber to isolate respective portions of thenerve situated between each adjacent pair of ridges.
 3. The nerve cuffaccording to claim 2, wherein said inner surface comprises a pluralityof protuberances extending between the proximal end and the distal end,each of the plurality of protuberances situated between one of theadjacent pairs of ridges and having at least one pair of contiguousconductors mounted thereto.
 4. The nerve cuff according to claim 2,further comprising a ground wire embedded within said ridges.
 5. Thenerve cuff according to claim 3, wherein said protuberance provides forpositioning each electrode at substantially the same level as saidridges relative to said inner surface.
 6. The nerve cuff according toclaim 3, wherein each pair of contiguous conductors is embedded within arespective said protuberance.
 7. The nerve cuff according to claim 3,wherein each said protuberance is apertured so as to expose each exposedportion of each said conductor thereby providing each said electrode. 8.The nerve cuff according to claim 3, wherein each said pair ofcontiguous conductors is mounted on a respective said protuberance. 9.The nerve cuff according to claim 8, wherein each said pair ofcontiguous conductors is mounted along substantially a full length ofsaid protuberance.
 10. The nerve cuff according to claim 1, wherein eachsaid conductor is embedded within said inner surface, said inner surfacebeing apertured so as to expose each exposed portion of each saidconductor thereby providing each said electrode.
 11. The nerve cuffaccording to claim 1, wherein each said conductor is mounted on saidinner surface.
 12. The nerve cuff according to claim 1, wherein saidinner surface further comprises at least one protuberance extendingalong the inner surface between the proximal end and the distal end,wherein at least one pair of contiguous conductors is mounted to saidprotuberance.
 13. The nerve cuff according to claim 12, wherein eachpair of contiguous conductors is embedded within each protuberance. 14.The nerve cuff according to claim 13, wherein said protuberance isapertured so as to expose each exposed portion of each said conductor ofthe at least one pair of contiguous conductors, thereby providing eachsaid electrode.
 15. The nerve cuff according to claim 12, wherein the atleast one pair of contiguous conductors is mounted on said protuberance.16. The nerve cuff according to claim 12, wherein a said protuberance isso configured as to provide for each electrode to be in contact with orat least near a surface of the nerve when said nerve cuff is mountedthereto.
 17. The nerve cuff according to claim 1, wherein each pair ofcontiguous conductors comprises a pair of wires.
 18. The nerve cuffaccording to claim 17, wherein said pair of wires are insulated, saidinsulation being removed at said at least one exposed portion situatedbetween the proximal end and the distal end providing said electrode.19. The nerve cuff according to claim 1, wherein an end of eachconductor protrudes beyond the proximal end or the distal end.
 20. Thenerve cuff according to claim 19, wherein said end is capped with aninsulating material.
 21. The nerve cuff according to claim 1, furthercomprising a ground wire mounted to said inner surface.
 22. The nervecuff according to claim 21, wherein said ground wire is embedded withinsaid inner surface.
 23. The nerve cuff according to claim 1, whereinsaid wall band member further comprises a closure for maintaining saidwall band member in said closed configuration.
 24. The nerve cuffaccording to claim 23, wherein said closure comprises mutuallyinterdigitating members positioned at each lateral side of said wallband member.
 25. The nerve cuff according to claim 24, wherein saidinterdigitating members are combined with a sealing tube.
 26. The nervecuff according to claim 24, wherein a rod-like member is insertedthrough said mutually interdigitating members when interdigitatedthereby closing said interdigitated members together.
 27. The nerve cuffaccording to claim 1, wherein said wall band member further comprisesone or more ports for connection to an agent delivery system.
 28. Anerve cuff comprising: a wall band member having proximal and distalends thereof, an inner surface defining a lumen extending between theproximal end and the distal end when said wall band member is in aclosed configuration for receiving a nerve therethrough; at least oneprotuberance extending along the inner surface between the proximal endand the distal end; and at least one pair of contiguous conductorsmounted to each said protuberance and extending along substantially afull length of the protuberance, wherein each conductor comprises atleast one exposed portion situated between the proximal end and thedistal end and an insulated remaining portion, and wherein each pair ofcontiguous conductors provides at least two electrodes; wherein, whenmounting said nerve cuff to a nerve, said at least one protuberanceprovides for said electrodes to be in contact with or at least near thesurface of the nerve.
 29. The nerve cuff according to claim 28, furthercomprising a plurality of ridges formed on said inner surface andextending between the proximal end and the distal end, wherein each pairof contiguous conductors mounted to each protuberance is situatedbetween each adjacent pair of ridges, each adjacent pair of ridges andeach portion of the inner surface situated between the adjacent pair ofridges defines a chamber, and wherein, when mounting said nerve cuff tothe nerve, said ridges abut the nerve providing for each said chamber toisolate respective portions of the nerve situated between each pair ofridges.
 30. The nerve cuff according to claim 29, wherein eachprotuberance provides for positioning each electrode at substantiallythe same level as said ridges relative to said inner surface.
 31. Thenerve cuff according to claim 30, wherein each pair of contiguousconductors comprises a pair of wires.
 32. The nerve cuff according toclaim 30, wherein each pair of contiguous conductors comprises an endprotruding beyond the proximal end or the distal end, said protrudingend being capped with an insulating material.
 33. The nerve cuffaccording to claim 28, further comprising a ground wire mounted to saidwall band member.
 34. The nerve cuff according to claim 28, wherein saidwall band member further comprises a closure.
 35. The nerve cuffaccording to claim 28, wherein said wall band member further comprisesports for connection to an agent delivery system.
 36. A nerve cuffcomprising: a wall band member having proximal and distal ends thereof,an inner surface defining a lumen extending between the proximal end andthe distal end when said wall band member is in a closed configurationfor receiving a nerve therethrough; a plurality of longitudinal ridgesformed on said inner surface and extending between the proximal end andthe distal end, each adjacent pair of said ridges defining a chamber; atleast one protuberance extending between the proximal end and the distalend, each protuberance situated between each adjacent pair of ridges;and at least one and pair of contiguous conductors mounted alongessentially a full length of the protuberance, each conductor beinginsulated and having at least one exposed portion situated between theproximal end and the distal end thereby providing at least oneelectrode, wherein, when mounting said nerve cuff to the nerve, saidridges abut the nerve providing for each said chamber to isolaterespective portions of the nerve situated between each adjacent pair ofridges, each said protuberance providing for each electrode to be incontact with or at least near the surface of the nerve.